DK Score Coronary Scoring Balloon: a RCT Trial to Evaluate Acute Lumen Gain (SCORE CHINA)

A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of DK ScoreTM Scoring Balloon Vesus Non-Slip Element Coronary Dilatation Catheter for Coronary Artery Stenosis

A prospective, Multi-center, Randomized Study designed to evaluate the acute lumen gain and device procedural success of the DK ScoreTM Scoring balloon versus NSE Scoring Balloon for patients with coronary arteries stenosis.

Study Overview

• Status: Completed
• Conditions: Coronary Stenosis
• Intervention / Treatment: Device: DK ScoreTM Coronary Scoring Balloon; Device: Non-Slip Element Coronary Dilatation Catheter

Detailed Description

This is a prospective, multi-center, randomized controlled, open-label, noninferior study to evaluate Acute Lumen Gain after dilatation. A total of 200 patients will be enrolled from 4 sites in China. All patients enrolled will be randomly assigned to the test group (DK ScoreTM group, n=100) and the control group (NSE group, n=100) with randomized allocation ratio of 1:1. Patients in the test group and the control group will be treated with DK ScoreTM Scoring balloon catheters or NSE Coronary Dilatation Catheter. A 30-day after procedure follow-up will be conducted for all 200 patients.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Anzhen Hospital affiliated to Capital University of Medical
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Xuzhou Third People Hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • Taiyuan Central Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Chest Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients related

1. Age ≥ 18 years and ≤ 75 years.
2. Patients with symptomatic coronary artery disease with stable and unstable angina pectoralis remote myocardial infarction , asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia.
3. Patients with indications for coronary artery bypass grafting.
4. Patients are able to follow protocol requirements and data collection procedures
5. Patients understand the purpose of the study, will voluntarily participate in the study and sign informed consent. Patients are willing to undergo clinical follow-up as required by this study.

Lesions Related:

1. Reference vessel diameter (RVD) between 2.0 and 4.0 mm by visual estimation.. Target lesion length ≤ 20 mm.
2. More than 70% stenosis (or more than 50% stenosis combined with symptoms of ischemia). TIMI≥1.
3. One target lesion needs to be Treated. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician. The non-target lesion need be located at another coronary artery different from the target lesion.
4. Investigator estimates that the target lesion need Cutting/Scoring balloon treatment. Target lesion is fully pre-dilated that scoring balloon is able to pass.

Exclusion Criteria:

Patients Related :

1. AMI within 1 week.
2. Patients has congestive heart failure or NYHA IV.
3. Renal dysfunctional (CRE>443umol/L).
4. Patient underwent heat transplant.
5. Pregnant or nursing.
6. Lifespan expectancy is less than 12 months
7. Patients with history of peptic ulcer or gastrointestinal bleeding, or the patients have a bleeding tendency evaluated by investigator. Patients are forbidden to use anticoagulation agents or anti-platelet drugs.
8. Patients are allergic to paclitaxel or heparin
9. Difficult for evaluation or treatment.
10. Patents are currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
11. Patients participated in any other clinical trials less than 1 month.
12. Interventional surgery is expected to be extremely risky unsuitable for study evaluated by investigator.
13. Patient had poor compliance record and could not follow the study.

Lesion Related:

1. Target Lesion located in Left Main Artery lesions and Ostial lesion within 5mm to Left Main Artery.
2. Angiography shows thrombus in Target Lesion
3. Chronic Total Occlusion Lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DK ScoreTM Coronary Scoring Balloon (DK Score); DK ScoreTM Coronary Scoring Balloon Manufactured by DK Medical Technolgy CO.,LTD	Device: DK ScoreTM Coronary Scoring Balloon; After pre-dilation balloon is used (if any), DK Score is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment.; Other Names: DK Score
Active Comparator: Non-Slip Element Coronary Dilatation Catheter (NSE); Non-Slip Element Coronary Dilatation Catheter Manufactured by GOODMAN CO.,LTD	Device: Non-Slip Element Coronary Dilatation Catheter; After pre-dilation balloon is used (if any), NSE is used as final dilatation balloon before Drug Eluting Stent implantation or Drug Coated Balloon deployment.; Other Names: NSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Acute Lumen Gain in mm (QCA)	Acute Lumen Gain for both arms will be measure with QCA, as accessed by independent core-lab. Angiographic endpoint will be in-lesion acute lumen gain defined as minimal lumen diameter (MLD) in lumen after dilatation by either arm device minus baseline MLD.	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Device success in percent	Successful delivery to the target lesion, deployment, achieving less than 50% residual stenosis, and retrieval after procedure.	During the procedure
Rate of Target Lesion Failure in percent	Defined as any Target Lesion Failure after procedure	30±7 Days
Rate of Patient-oriented Composite Endpoint (POCE) in percent	Patient-oriented Composite Endpoint after procedure	30±7 Days
Rate of other Complications in percent	Incidence of complications associated with the use of scoring balloon catheters	During the procedure
Rate of Clinical Success in percent	Defined as <20% diameter stenosis after stenting for DCB, without in-hospital major adverse cardiac events/MI/TLR After PCI	During the procedure

Collaborators and Investigators

• Sponsor: DK Medical Technology (Suzhou) Co., Ltd.
• Investigators: Principal Investigator: Yujie Zhou, Dr., Beijing Anzhen Hospital affiliated to Capital University of Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): September 2, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Scoring balloon; DK Score; NSE
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Coronary Disease; Constriction, Pathologic; Coronary Stenosis
• Other Study ID Numbers: VP-P-2019-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No